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Cola

Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.

The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.

ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

ctDNA analysis after surgery

Miriam Koopman, Prof. dr.

J.F.M. Pruijt

M.P. Hendriks

R. Hoekstra

J.D.W. van der Bilt

J.M. van Dodewaard

I. Werter

M. Streppel

A.J. Verschoor

F.J.F. Jeurissen

L.W. Kessels

M. Vidakovic

M. Verstappen

H.K. van Halteren

M.A. Davidis

H.B.A.C. Stockmann

A.P. Schouten van der Velden

L.B.J. Valkenburg

A.I. de Vos

M. Los

J. Janssen

S. Boudewijns

F.E. de Jongh

J. van Extel

L. van Leeuwen

Miriam Koopman

L.H.J Simkens

N.A.J.B. Peters

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).

Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

Proportion of patients that will experience disease recurrence

Proportion of patients that are alive and free of disease

Quality of Life will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.

Personal Genome Diagnostics (PGDx)

The Netherlands Cancer Institute

UMC Utrecht

Prof. dr.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial	NCT06434896	Circulating Tum... Recurrence Colon Cancer St...	ctDNA analysis ...	18 Years -	UMC Utrecht
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial	NCT06434896	Circulating Tum... Recurrence Colon Cancer St...	ctDNA analysis ...	18 Years -	UMC Utrecht

Spots Global Cancer Trial Database for ctdna analysis after surgery